CAHP-150 CELLULOSE DIACETATE DIALYZER
Received Nov 5, 2010 · Event occurred Oct 3, 2010
Report 1423500-2010-05299 · MDR key 1891586
Device
Generic name
Hemodialyzer, Re-use, High Flux
Manufacturer
Nipro Corporation *usd*Catalog number
5M2734
Lot number
09G02D
Product problems
- Fluid/Blood Leak
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). THIS COMPLAINT WAS CONFIRMED IN THE LAB. THE EVALUATION FOUND THAT THERE WAS LEAKAGE AT THE VENOUS HEADER AND BUBBLING OUT OF THE DIALYSATE PORT. NO ROOT CAUSE WAS IDENTIFIED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND DURING THE MANUFACTURE OF THE LOT. A REVIEW OF THE MANUFACTURING, PROCESS INSPECTION AND RELEASE INSPECTION RECORDS WAS PERFORMED AND NO DEFECTS WERE NOTED. IN ADDITION, TESTING OF THE RETAINED SAMPLES SHOWED NO ABNORMALITIES. RENAL QUALITY ENGINEERING, ALONG WITH PLANT MANUFACTURING AND QUALITY PERSONNEL, WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.
Description of Event or Problem
A CUSTOMER REPORTED TO BAXTER AN INCIDENT INVOLVING A DIALYZER. THE CUSTOMER STATED THAT THERE WAS A LEAK AT THE FIBER AT THE 4TH TIME OF REUSE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.
Additional Manufacturer Narrative
(B)(4). THE DEVICE/PRODUCT SAMPLE HAS BEEN RECEIVED BY BAXTER; HOWEVER, THE EVALUATION HAS NOT BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.